Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection

Hepatocellular Carcinoma Clinical Trial

— JUPITER 04  

Official title:

A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Toripalimab (Recombinant Humanized Anti-PD-1 Monoclonal Antibody, JS001) Versus Placebo as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence Following Radical Resection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03859128
• Other study ID #: JS001-016-III-HCC
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: March 5, 2019
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2023
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 402
• Est. completion date: August 1, 2023
• Est. primary completion date: April 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection;

2. BICR confirmed no resdual tumor lesions are detected in liver;

3. Child-Puch score, Class A;

4. ECOG score is 0;

Exclusion Criteria:

1. Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study;

2. Portal vein tumor thrombi or liver metastases or recurrent liver cancer;

3. With symptoms of central nervous system metastasis;

4. With any history of active autoimmune disease or autoimmune disease;

5. Known liver diseases with clinical significance;

6. Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV): Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Biological:
• TORIPALIMAB INJECTION(JS001 )
Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W

Locations

Country	Name	City	State
China	Zhongshan Hospital,Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BICR-RFS	Defined as the time from randomization to the first documented disease recurrence or death.	Time frame is up to 31 months (for interim analysis, up to 44 months for Primary analysis)
Secondary	Investigator-RFS	the time from randomization to the date of the first documented progressive disease (tumor evlauation by BICR in accordance with RECIST 1.1), or to the date of death for any cause, whichever occurs first	up to 44 months
Secondary	12-month recurrence-free survival rate (RFS12)	probability of patients without recurrence or death for any cause at Month 12	up to 44 months
Secondary	24-month recurrence-free survival rate (RFS24)	probability of patients without recurrence or death for any cause at Month 24	up to 44 months
Secondary	Time to recurrence (TTR)	the time from randomization to the first documented disease recurrence	up to 44 months
Secondary	Time to local recurrence (TTLR)	the time from randomization to the first documented local disease recurrence	up to 44 months
Secondary	Overall survival (OS)	the time from randomization to death for any cause	up to 44 months
Secondary	12- and 24-month overall survival rate (OS12 and OS24)	probability of patients surviving at Month 12 and 24, respectively	up to 44 months
Secondary	Incidence of AEs	Incidence of AEs (including SAEs and AESIs) is evaluated by the investigator, and severity is determined in accordance with CTCAE v5.0	up to 44 months